Methods and devices for retrieving a subject's physiological history from a biological sample analysis

Abstract

Methods and devices for retrieving a subject's physiological history from a single sample or measurement are disclosed. Methods and devices for obtaining a blood glucose history from a single blood sample are disclosed.

1 . A method of obtaining a subject's physiological history from a sample analysis, the method comprising the steps of: 
 (a) measuring an amount of a cellular modification for each of a plurality of cells from a biological sample;    (b) sorting the cell measurements from step (a) as a function of the amount of modification; and,    (c) determining a physiological history for the subject by analyzing the ordered cell measurements.    
     
     
         2 . The method of  claim 1 , wherein the physiological history is indicative of a disease or disorder in the subject.  
     
     
         3 . The method of  claim 2 , wherein the disease or disorder is diabetes.  
     
     
         4 . The method of  claim 3 , wherein the diabetes is Type I diabetes.  
     
     
         5 . The method of  claim 3 , wherein the diabetes is Type II diabetes.  
     
     
         6 - 18 . (canceled)  
     
     
         19 . A method of obtaining a cell distribution profile of a patient, the method comprising the steps of: 
 (a) obtaining a biological sample comprising intact cells; and    (b) determining a cell distribution profile for a plurality of the intact cells using a procedure that sorts the intact cells based on an amount of a physiological variable in each of the sorted cells.    
     
     
         20 - 24 . (canceled)  
     
     
         25 . A method for recovering the blood glucose level history of a patient diagnosed with diabetes, the method comprising the steps of: 
 (a) obtaining a blood sample comprising intact cells    (b) obtaining a cell distribution profile by sorting a plurality of the intact cells based on the amount of glycated hemoglobin in each cell; and,    (c) determining the patient's glucose level history based on the cell distribution profile.    
     
     
         26 . The method of  claim 25 , wherein the patient's blood glucose level history is obtained by comparing the patient's cell distribution profile to one or more reference profiles.  
     
     
         27 . The method of  claim 25 , wherein the patient's blood glucose level history is obtained using an algorithm.  
     
     
         28 . The method of  claim 27 , wherein the algorithm corrects for non-linearity in the rate of hemoglobin glycation.  
     
     
         29 . The method of  claim 27 , wherein the algorithm uses patient specific input data.  
     
     
         30 . The method of  claim 29 , wherein the patient specific input data is selected from the group consisting of the patient's age, gender, and weight.  
     
     
         31 . The method of  claim 27 , wherein the algorithm uses a value for the average life span of a red blood cell.  
     
     
         32 . The method of  claim 25 , wherein the intact cells are sorted using a procedure selected from the group consisting of chromatography, electrophoresis, mass spectrometry, and cell sorting.  
     
     
         33 . The method of  claim 25 , comprising the additional step of determining whether the patient has Type I, Type II, or gestational diabetes.  
     
     
         34 . The method of  claim 25 , comprising the additional step of determining a treatment regimen for the patient.  
     
     
         35 . The method of  claim 25 , comprising the step of obtaining a second blood sample at a second time and performing steps (b) and (c) on the second blood sample.  
     
     
         36 . The method of  claim 25 , wherein the glycosylated hemoglobin is labeled.  
     
     
         37 . A chromatography device for separating blood cells based on levels of glycosylated hemoglobin, the device comprising: 
 (a) a high pressure column comprising a sample chamber and a tapered exit hole;    (b) a dynamic light scattering detector connected to the exit hole; and,    (c) a gas powered injector connected to the sample chamber.    
     
     
         38 . An electrophoretic device for separating blood cells based on levels of glycosylated hemoglobin, the device comprising: 
 (a) a liquid flow column with a sample entry point and a plurality of collection points along the length of the column; and,    (b) an electromagnetic field generator associated with the column, wherein the electromagnetic field is normal to the direction of the liquid flow.